EP1977757B1 - Lutschpastille enthaltend Pelargonium in Kombination mit Plantago - Google Patents

Lutschpastille enthaltend Pelargonium in Kombination mit Plantago Download PDF

Info

Publication number
EP1977757B1
EP1977757B1 EP08011644.5A EP08011644A EP1977757B1 EP 1977757 B1 EP1977757 B1 EP 1977757B1 EP 08011644 A EP08011644 A EP 08011644A EP 1977757 B1 EP1977757 B1 EP 1977757B1
Authority
EP
European Patent Office
Prior art keywords
lozenge
pelargonium
extract
plantago
plantain
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP08011644.5A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP1977757A2 (de
EP1977757A3 (de
Inventor
Ernst Dr. Schneider
Michael Dr. Ploch
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Divapharma Chur AG
Original Assignee
Divapharma Chur AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Divapharma Chur AG filed Critical Divapharma Chur AG
Priority to PL08011644T priority Critical patent/PL1977757T3/pl
Priority to EP08011644.5A priority patent/EP1977757B1/de
Priority to ES08011644.5T priority patent/ES2662889T3/es
Publication of EP1977757A2 publication Critical patent/EP1977757A2/de
Publication of EP1977757A3 publication Critical patent/EP1977757A3/de
Application granted granted Critical
Publication of EP1977757B1 publication Critical patent/EP1977757B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/68—Plantaginaceae (Plantain Family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/04—Drugs for disorders of the respiratory system for throat disorders

Definitions

  • the present invention relates to a lozenge containing Pelargonium in combination with Plantago, which is a two-layered lozenge, whose core layer is formed by a plantain composition (Plantago lanceolata) and whose outer coating is formed by the Pelargonium component.
  • the present description relates to a lozenge, which contains Pelargonium in combination with Plantago and is particularly suitable for the topical prophylaxis and treatment of inflammation of the mouth and throat.
  • the field of phytopharmaceuticals is becoming increasingly important.
  • plants or plant extracts are already known, to which certain advantageous effects are attributed. These include Pelargonium sidoides and plantain.
  • Plantago ribwort plantain and common plantain
  • DE202004016077 discloses lozenges for use in the topical treatment of oropharyngitis, the lozenges including Plantago lanceolata.
  • a receptor-mediated effect requires a specific receptor for the active substance (key-lock principle). This leads to displacement effects between the test substance (eg ⁇ -blocker) and the body's own ligand (eg adrenaline), which results in a typical dose-dependency. If a substance binds to a receptor, it triggers a physiologically prescribed reaction or reaction sequence, which can be measured as a typical effect in pharmacological experiments.
  • topical treatments are not based on receptor interactions; rather, topical treatments are due to purely physical or physicochemical processes.
  • Such diseases or disorders are z. B. inflammatory reactions such. B. in the throat, throat or mouth.
  • the inflammation of the oropharynx is of great importance, since these are still extremely common and it remains difficult to treat such inflammations both from the ground up as well as symptomatically.
  • the lozenge contains pelargonium in combination with Plantago, wherein when using the lozenge first effect of the pelargonium constituent, and subsequently the action of the plantain constituent, which is a two-layered lozenge, wherein an inner core layer is formed by the ribwort constituent and an outer coating is formed by the Pelargonium component.
  • Pelargonium species Pelargonium sidoides and / or Pelargonium reniforme.
  • Plantago species Plantago lanceolata and Plantago major are preferred.
  • the lozenge invention aims at a topical prophylaxis or treatment, d. H.
  • the disease to be treated is a disease of the oropharynx. It is z.
  • inflamed proteins in the mouth and throat area can be achieved only topically from the Pelargonium extract and plantain extract, and consume itself, without a systemic absorption of the active ingredients takes place. In this way it is achieved in a particularly preferred manner that the systemic side effects attributed, albeit slight, to Pelargonium or ribwort plantain should not occur in the present case of topical application.
  • the dosage forms according to the present invention are formulated such that initially the effect of the pelargonium component predominates, whereupon the action of the plantain predominates.
  • a release pattern can be realized in a manner known to those skilled in the art. For example, it is possible to formulate pelargonium and ribwort with different carriers that release their active ingredients in different ways.
  • pelargonium can be formulated with a slightly soluble sugar alcohol while ribwort is mixed with a sparingly soluble sugar alcohol. In this way results in a release pattern, initially outweighing the effect of Pelargonium component.
  • the tannins of the Pelargonium component can first crosslink the proteins in the oral mucosa, whereupon the active ingredients of the plantain can put a protective layer of mucus on the same.
  • the formulation in liposomes which is also known to those skilled in the art.
  • the sucking-pastille according to the invention is a two-layered sucking-pastille, which is constructed such that first the Pelargonium component and subsequently or temporally overlapping the Spitzwegerich ingredient is released.
  • the invention here expressly includes such embodiments in which the components pelargonium and ribwort plantain time-wise offset from each other, d. H. be released sequentially, as well as those in which plantain and Pelargonium are initially released together, possibly in a majority of Pelargonium, followed by a phase in which predominantly or exclusively plantain is released.
  • the lozenge according to the present invention contains pelargonium in combination with plantain, namely Plantago lanceolata, which can be used in the form of a dry extract.
  • plantain namely Plantago lanceolata
  • Another preferred use, in particular the combination of an aqueous-ethanolic extract of Pelargonium sidoides and / or reniforme with dry extract from plantain is in the same dosage form, ie in the form of a lozenge.
  • the lozenge invention is preferably used for the treatment of inflammation in the mouth and throat.
  • the disorders or diseases to be treated or the disorders or diseases which are to be prevented are, in particular, inflammation of the mouth or throat.
  • the tannins released by Pelargonium sidoides will initially crosslink proteins of the inflamed mucosa in and around the throat. Infections will be prevented or existing infections will be weakened.
  • the lozenges of ribwort removed from the lozenge subsequently surround the mucous membranes with a protective film. This mucus effect is aided by the property of the optional Arabic gum to swell with water to form a mucilaginous hydrocolloid.
  • This function is achieved by the dosage form of the lozenges, which are sucked so that they remain as long as possible in the oral cavity.
  • the tannins first crosslink the inflamed proteins of the (mucus) skin and then the mucilage the Spitzwegerichkrauts adhere to the tannins, wherein the cross-linking of mucilage by u.
  • U. not completely intercepted tannins has the beneficial effect that the mucilage better adhere to the inflamed tissue and thereby exert their protective function in a particularly advantageous manner.
  • the tannins are usually dosed so low that an essential component will already be consumed by the cross-linking of the inflamed proteins; Any remaining residual tannins would then crosslink the mucilage.
  • the inventive lozenge comprising a combination of Pelargonium and Plantago is a two-layered lozenge, wherein an inner core layer is formed by the ribwort constituent and an outer coating is formed by the Pelargonium component.
  • the above-mentioned effect is particularly preferably achieved by first sucking the outer coating formed by the Pelargonium component and thereby crosslinking the proteins of the inflamed mucous membrane in the oropharynx, while after crosslinking by the Pelargonium component
  • the inner core layer formed by the ribwort plantain component is sucked, and the already cross-linked proteins are then coated with a protective film.
  • the following additives are particularly preferred in the present context: Arab gum, maltitol, sorbitol, Xylitol, sucrose, isomalt, water-free citric acid, acesulfame potassium, low-viscosity paraffin, bleached wax, water, cellulose derivatives, sugar alcohols, Eudragit and / or flavoring agents, in particular, these are suitable for the formulation of a lozenge.
  • the flavorings are preferably geranium oil, and / or menthol.
  • a lozenge comprising a combination of Pelargonium extract and plantain extract comprising 80 to 200 mg of Pelargonium mother tincture and 15 to 40 mg of plantain extract.
  • such a lozenge comprises 100.00 mg of Pelargonium mother tincture and 25.00 mg of plantain extract.
  • each is a 90% native extract.
  • composition for such a lozenge Pelargonium mother tincture: 80-200 mg Plantain dry extract: 15-40 mg Arabian gum: 300 - 500 mg maltitol: 400 - 600 mg Sorbitol solution 70% (non-crystallizing): 100-200 mg Anhydrous citric acid: 4 - 9 mg Menthol: 0 - 100 mg Acesulfame potassium: 0.3-1 mg Geranium oil, of course: 0 - 0.1 mg Thin liquid paraffin: 0-2 mg Bleached wax: 0 - 0.1 mg Process water: qs
  • the preferred ratio of pelargonium dry matter to ribwort dry extract is 1:50 to 1: 8, more preferably 1:40 to 1:20, even more preferably about 1:25 (w / w).
  • the following embodiment is for such a lozenge: Pelargonium mother tincture: 100 mg Plantain dry extract: 25 mg Arabian gum: 412 mg maltitol: 553 mg Sorbitol solution 70% (non-crystallizing): 143 mg Anhydrous citric acid: 6.50 mg Menthol: 0.80 mg Acesulfame potassium: 0.5 mg Geranium oil, of course: 0.05 mg Thin liquid paraffin: 1.30 mg Bleached wax: 0.7 mg Process water: qs, at one Pastille weight of 1,000.00 mg.
  • Arabic gum maltitol, sorbitol, anhydrous citric acid, acesulfame potassium, paraffin wax, bleached wax, water, flavoring (geranium oil, menthol), sugar alcohols of varying solubility.
  • a preferred purpose would be an application to relieve the symptoms of mild and moderate diseases of the oropharynx.
  • the lozenges should be sucked so that they remain as long as possible (about 10 minutes) in the mouth.
  • the tannins released by Pelargonium sidoides will crosslink proteins of the inflamed mucosa in the mouth and throat. Infections will be prevented or existing infections will be weakened.
  • the lozenges of ribwort removed from the lozenge subsequently surround the mucous membranes with a protective film. This mucus effect is aided by the property of the optional Arabic gum to swell with water to form a mucilaginous hydrocolloid.
  • This function is achieved by the dosage form of the lozenges, which are sucked so that they remain as long as possible in the oral cavity.
  • Another conceivable form of administration would be a formulation in which pelargonium is contained in a higher dosage than the one mentioned above.
  • This higher dosage would have the advantage that, in addition to the topical beneficial effect, the Pelargonium tannins could also act directly at the site of the immunological center in the throat, namely the Waldeyer's throat ring.
  • tannins have an immune system supporting effect.
  • it has been found according to the present invention that the combination of pelargonium and plantain in the case where Pelargonium is used in high doses has a synergistic effect, since the highly branched polysaccharides of the ribwort weed also stimulate immune-competent cells.
  • the previous crosslinking of the tanning agents not only allows the mucus layer of the mucilage of the ribwort plantain to accumulate loosely but also to adhere firmly to a network. This effect can synergistically improve the effect of the lozenge even on low-dose tannins.
  • Pelargonium extract an aqueous-ethanolic extract from the root of Pelargonium sidoides in the form of a mother tincture, the above-explained tannin effect stands in the foreground for the lozenge.
  • Tanning agents were originally understood to be plant extracts which were used for the tanning of animal skin and for the production of leather. Since the leather industry today predominantly uses chemical substances, it is only interested in the astringent effect of this natural product class in pharmacy and cosmetics.
  • This astringent action is based on an interaction with protein molecules of the collagen fibers of the uppermost tissue layers of the skin and mucous membranes. This effect is exhibited only by tanning agents having a molecular weight between 500 and 3000 and one to two hydroxyl groups per 100 mass units.
  • plants form tannins as secondary ingredients to repel predators (herbivores, insects) and phytopathogenic infectious agents (fungi, bacteria, viruses).
  • the substance class is divided into condensed and hydrolyzable tannins.
  • tannins can be cleaved by hydrolysis into sugars and gallic acid or ellagic acid (hexahydroxydiphenic acid). Therefore, one distinguishes gallotannins and ellagitannins.
  • Typical representative is the "tannin” (hexagalloylglucose) or the digallic acid. Frequently, mixed compounds also occur which on hydrolysis give both gallic acid and catechol, e.g. the epicatechingallate from black tea.
  • the total tannin content in the roots of Pelargonium sidoides is approximately 9% in the dry matter (TM) (Kolodziej, H., Kayser, O. Pelargonium sidoides DC - Recent findings on the understanding of the phytotherapeutic Umckaloabo, Z. Phytother. 19: 28 (1998)).
  • the content of hydrolysable tannins is very low, since the values found for gallic acid are less than 0.01% in TM and for gallic acid methyl ester about 0.02% in TM ( Kayser, O .: Phenolic ingredients of P. sidoides. Diss. FU Berlin D188, 1997 ).
  • catechin gelling agents for which catechin and gallocatechin are the most widely used monomers, have also been found to have a low level of afzelechin (Kolodziej 1998, supra). These monomers are in a complex composition of polymeric structures of at least eight flavonol units whose molecular weight is about 2300 and thus still in the range of an astringent effect.
  • tanning agent is completely bound and represented by the difference of the optical extinction of a color reaction before and after the adsorption 1E1 (750) - E2 (750) j (Grazca, 1987, supra).
  • the adsorption value tends to a limit.
  • the resulting curve (adsorption vs. concentration) is completely different from a pharmacological dose-response relationship.
  • the present ratios are known from physical chemistry and are commonly described by the Langmuir equation for adsorption isotherms.
  • the graph reproduced above in FIG. 1 represents the lower, linear part of the curve according to FIG. 2.
  • Adstringens effect is when the tanning agent cross-links the protein molecules (e.g., collagen fibers) with less stable ion or hydrogen bonds.
  • protein molecules e.g., collagen fibers
  • Adstringens effect is when the tanning agent cross-links the protein molecules (e.g., collagen fibers) with less stable ion or hydrogen bonds.
  • the amount of tannins present in the lozenge although bound to the oral mucosa, but can not penetrate the epithelial barrier and thus is not absorbed.
  • compositions claimed here according to the invention also differs significantly previously described compositions containing pelargonium and pelargonium extracts, all of which aim for systemic effects and therefore also require higher dosages.
  • the tannins released from pelargonium extract of the lozenge nourish proteins of the inflamed mucosa in the mouth and throat due to their astringent properties. These are purely physicochemical mechanisms of action of adsorption and ionic bonds, which by definition are not counted as pharmacological effects. Due to the mechanism of action of superficial adsorption, tannin in the oral cavity is also not absorbed.
  • the envelope-covering effect of the mucilages is the focus of the preparation according to the invention.
  • mucus polysaccharides are usually heteropolysaccharides, ie polymeric carbohydrates from glycosidically linked sugars, which do not stick even in highly viscous solutions. Depending on the proportion of uronic acid units, these hydrogels may react neutral or acidic. Due to the primary structure The polymers can be divided into mannans, glucomannans, galactomannans, xylans, rhamnogalacturones, etc., wherein in slime-forming plants usually different chemically distinguishable biopolymers occur. The molecular weight of the mucus polysaccharides is of the order of 5 ⁇ 10 4 -10 6 .
  • the leaves of plantain plantago lanceolata contain 2 - 5% of mucus polysaccharides consisting of the monomers glucuronic acid 7%, galacturonic acid 31%, galactose 44%, arabinose 32%, glucose 9%, rhamnose 7%, mannose 4%, fucose and xylose.
  • the raw mucus can be further divided into four fractions consisting of one neutral and several acidic polysaccharide fractions.
  • plantain contains 2-4% iridoids with the main components Aucubin and Catalpol, as well as tannins, flavonoids, phenolcarboxylic acids (caffeic acid, ferulic acid) and phenylethanoids, such as acetoside (Paper DH, Marchesan M, Plantain (Plantago lanceolata L.) Z. Phytother. 20, 231-238, 1999 ).
  • the anatomy of the oral mucosa shows an epithelial layer which is supported by a layer of connective tissue ( lamina basement membrane ), from which it is separated by a basement membrane.
  • connective tissue lamina propria
  • This is keratinized on the gums and palate.
  • the remainder of the mucosa - except at the base of the tongue - shows 4 layers (superficial, intermediate, prickle-cell and basal layer).
  • the thickness of the epithelium is 500 - 600 pm, with a total area of approx. 50 cm 2 .
  • the "membrane-coating granules" of the "prickle-cells” are lipid-containing organelles whose contents are released into the intercellular spaces and are responsible for the cell cohesion and the intercellular barrier.
  • the oral mucosa has no tight junctions between the epithelial cells, as they are typical of the intestinal mucosa (in the intestine).
  • the mucous layer of the oral mucosa moisturizes and protects the epithelium and makes it lubricious.
  • the actual mucus, called mucin is a glycoprotein whose protein core is surrounded by oligosaccharide side chains. This also causes the pH of 5.8 - 7.4 of the saliva.
  • Saliva also contains physiological mucus substances.
  • 3 types of polysaccharides are present at a concentration of 50-300 mg / 100 ml.
  • Fucomucoids contain fucose, hexosamine, galactose and some mannose, while the sialomucoids are rich in sialic acid and acetylgalactosamine. The low abundance acidic glycosaminoglycans have not been studied in detail.
  • the binding of the mucus to the cultured oral mucosal cells can be measured by decreasing the concentration of polysaccharides in the supernatant solution. The extent and speed of the effect depends on the mucus drug used.
  • FIG. 4 shows the binding of the mucilage to oral mucosal cells (histochemical examination).
  • the fluorescence-labeled rhamnogalacturonan used here is attached only apically to the epithelium [ep: epithelium, ct: connective tissue, bc: basal cells, d: lymph vessel] ( Schmidgall J. Schnetz E, Hensel A., Evidence for bioadhesive effects of polysaccharides and polysaccharide-containing herbs in an ex vivo bioadhesion assay on buccal membranes, Planta Med. 2000 Feb; 66 (1): 48-53 )
  • the binding of the mucus to the cultured oral mucosal cells can be measured by decreasing the concentration of polysaccharides in the supernatant solution.
  • the adsorption of the mucus on the cells is therefore a concentration-dependent process whose kinetics corresponds to the image of an adsorption isotherm (Schmidgall 2000 supra).
  • the resulting curve (adsorption versus concentration) is completely different from one pharmacological dose-response relationship.
  • the present ratios are known from physical chemistry and are usually represented by the Langmuir equation for adsorption isotherms.
  • the mucilaginous substances released from plantain extract from the medical device are deposited on the inflamed mucosa in the mouth and throat. These are purely physico-chemical mechanisms of adsorption, which by definition are not counted as pharmacological effects. Due to the mechanism of action of the reversible adsorption on the epithelial surface, mucous substances in the oral cavity are also not absorbed.
  • oral and pharyngeal therapeutics should be mentioned as possible fields of application of the present invention.
  • the necessary symptomatic treatment consists of alleviation of these conditions with the aim of improving the subjective condition of the patient.
  • the extract according to the invention or the combination according to the invention is preferably formulated in the dosage form usually used, but in particular one which allows topical administration of the invention to the inflamed site.
  • the present invention contains the tannin-containing plant Pelargonium and the mucilaginous plant ribwort.
  • the tannins should cross-link proteins of the inflamed mucosa in the mouth and throat. Infections are thus prevented.
  • the mucus envelops the mucous membranes in the mouth with a protective film.
  • Adstringentia result in a densification of the colloidal structure and a superficial seal on the mucosa of the oropharynx. Since the concentration ratio of tannin molecules to protein is very small, it comes only to a superficial complexation of the protein molecules on the polyphenol molecules and thus to form a coherent and protective membrane. This reduces the irritation of the mucous membrane and achieves a mild antibacterial and anesthetic effect.
  • the endogenous mucosal lining of the epithelium is disturbed in its function, resulting in chemical and microbial irritation.
  • the effect of mucilage in this application is that the mucus polysaccharides thinly attach to the upper layers of the oral mucosa and thus on a inflamed oral mucosa a - the natural mucus layer physiologically similar - protective film. This leads to rehydration, desensitization of the pain receptors and decrease of the local inflammation with the consequence of a decreased cough irritation.
  • the raw material Arabian gum (Acacia gum, Acacia senegal), from which the pastilles are preferably made, forms with water up to 50% colloidal solutions, which show no tendency to gel but adhere. From the highly branched arabinogalactans of Arabian gum form with water highly viscous hydrocolloid solutions that enhance the mucus sensation of plantain in the mouth.
  • a lozenge causes a mechanical stimulus which, together with the acidic citric acid and the excipients maltitol and sorbitol, causes a so-called sialagogenic effect, ie stimulates the salivary glands to secrete.
  • the oral mucosa is rinsed and natural mucus is distributed from the saliva in the mouth.
  • the inventors have discovered in the development of the dosage form that the mother tincture can be incorporated directly into lozenges; then the amount equivalent to 2 mg of 100 mg of mother tincture is used.
  • the urine tincture contains only 1% of the dry matter. This should be taken into consideration when interpreting the amounts of mother tincture used in pelargonium and plantain.
  • Determining the effectiveness of the product according to the invention is the tannin content and mucilage content of the pastilles.
  • This ingredient represents the mucilage activity of the inventive product.
  • a commercial dry extract has a DEV of 4-5: 1.
  • lozenge lozenge according to the invention contains, for example:
  • pastilles is based here on the use of Arabian gums or other hydrocolloids.
  • active ingredients and auxiliaries are incorporated in a known manner.
  • the resulting syrupy mass is poured into prefabricated powder forms on a so-called Mogul plant and then gently dried, powdered and shined.
  • an easily soluble sugar alcohol is used for the one layer and a less soluble one for the second layer.
  • a viscosity enhancer can be used in the sparingly soluble layer.
  • Cellulosic derivatives or arabic gums are suitable for this purpose. For tableting, these are used to pellet the extracts to improve the flowability of the pellet mass on the press.
  • the mother tincture can be grown on sucrose and dried.
  • the flavorings are incorporated into this layer.
  • the first two substances taste predominantly sweet and harmonize with the herbaceous taste of ribwort extract.
  • the product tastes sweet-cooling by the combination of xylitol and menthol with an exotic touch through the geranium. This is distracted by the tannin effect of Pelargonium flavor.
  • the tannins quickly cross-link and seal the proteins of the irritated mucosa.
  • the outer layer of the lozenge dissolves relatively quickly.
  • the predominantly sweet-herbaceous-tasting second layer is slowly dissolved with the mucilage.
  • the mucus, together with the sticky Arabian gum, lay like a film on the irritated mucous membranes of the mouth and throat and so calm the irritated neck.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Mycology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Zoology (AREA)
  • Otolaryngology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Cosmetics (AREA)
  • Medicinal Preparation (AREA)
  • Cultivation Of Plants (AREA)
  • Feed For Specific Animals (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
EP08011644.5A 2006-03-01 2006-03-01 Lutschpastille enthaltend Pelargonium in Kombination mit Plantago Active EP1977757B1 (de)

Priority Applications (3)

Application Number Priority Date Filing Date Title
PL08011644T PL1977757T3 (pl) 2006-03-01 2006-03-01 Pastylka do ssania zawierająca roślinę z rodzaju pelargonia w kombinacji z rośliną z rodzaju babka
EP08011644.5A EP1977757B1 (de) 2006-03-01 2006-03-01 Lutschpastille enthaltend Pelargonium in Kombination mit Plantago
ES08011644.5T ES2662889T3 (es) 2006-03-01 2006-03-01 Pastilla para chupar que contiene Pelargonium en combinación con Plantago

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP08011644.5A EP1977757B1 (de) 2006-03-01 2006-03-01 Lutschpastille enthaltend Pelargonium in Kombination mit Plantago
EP06004114A EP1829548B1 (de) 2006-03-01 2006-03-01 Verwendung von Pelargonium Extrakten in Kombination mit Plantago zur Herstellung eines Medikaments zur Behandlung der Rachenentzündung

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
EP06004114A Division EP1829548B1 (de) 2006-03-01 2006-03-01 Verwendung von Pelargonium Extrakten in Kombination mit Plantago zur Herstellung eines Medikaments zur Behandlung der Rachenentzündung

Publications (3)

Publication Number Publication Date
EP1977757A2 EP1977757A2 (de) 2008-10-08
EP1977757A3 EP1977757A3 (de) 2009-04-22
EP1977757B1 true EP1977757B1 (de) 2017-12-20

Family

ID=36716801

Family Applications (2)

Application Number Title Priority Date Filing Date
EP06004114A Active EP1829548B1 (de) 2006-03-01 2006-03-01 Verwendung von Pelargonium Extrakten in Kombination mit Plantago zur Herstellung eines Medikaments zur Behandlung der Rachenentzündung
EP08011644.5A Active EP1977757B1 (de) 2006-03-01 2006-03-01 Lutschpastille enthaltend Pelargonium in Kombination mit Plantago

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP06004114A Active EP1829548B1 (de) 2006-03-01 2006-03-01 Verwendung von Pelargonium Extrakten in Kombination mit Plantago zur Herstellung eines Medikaments zur Behandlung der Rachenentzündung

Country Status (8)

Country Link
EP (2) EP1829548B1 (es)
AT (1) ATE422161T1 (es)
DE (1) DE502006002773D1 (es)
DK (1) DK1829548T3 (es)
ES (2) ES2321432T3 (es)
PL (2) PL1829548T3 (es)
PT (1) PT1829548E (es)
SI (1) SI1829548T1 (es)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2453770A (en) * 2007-10-19 2009-04-22 Reckitt Benckiser Healthcare Oral composition comprising a cooling agent
DE202008008532U1 (de) * 2008-06-30 2009-08-13 Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh Lutschzusammensetzung zur Behandlung von entzündlichen Erkrankungen des Mund- und Rachenraums
GB2481630A (en) * 2010-07-01 2012-01-04 Robert Taylor Composition for dental health
DE102012003286A1 (de) * 2012-02-20 2013-08-22 Merz Pharma Gmbh & Co. Kgaa Kombination aus Lipidtransferproteinen und Phenolderivate enthaltenden Pflanzenstoffen mit lokal-mucosaler Effizienz
ES2634149T3 (es) 2012-10-17 2017-09-26 Montero Gida Sanayi Ve Ticaret A.S. Formulaciones que comprenden extractos herbáceos
EP2908834B1 (en) 2012-10-17 2017-07-12 Montero Gida Sanayi Ve Ticaret A.S. New formulations comprising plant extracts
TR201802779T4 (tr) 2012-10-17 2018-03-21 Montero Gida Sanayi Ve Ticaret Anonim Sirketi Bitkisel formülasyonlar.
WO2014060525A1 (en) 2012-10-18 2014-04-24 Montero Gida Sanayi Ve Ticaret A.S. Stable formulations
ITMI20130529A1 (it) * 2013-04-08 2014-10-09 I R B Istituto Di Ricerche B Iotecnologiche S P A Processo di produzione di cellule meristematiche di plantago lanceolata, composizione comprendente dette cellule o il loro estratto cellulare e l'utilizzo cosmetico, nutraceutico e dermatologico
CN104042701B (zh) * 2014-05-11 2016-02-03 黄涵 清咽含片
WO2022108540A1 (en) * 2020-11-19 2022-05-27 Montero Gida Sanayi Ve Ticaret Anonim Sirketi An herbal oral composition comprising natural ingredients

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
LU83173A1 (fr) * 1981-02-27 1981-06-05 Oreal Nouvelles compositions cosmetiques pour le traitement des cheveux et de la peau contenant une poudre resultant de la pulverisation d'au moins une plante et un agent de cohesion
US6027716A (en) * 1997-04-02 2000-02-22 Farmo-Nat Ltd. Synergistic herbal extracts
DE202004016077U1 (de) * 2004-09-22 2005-11-10 Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh Lutschtablette gegen entzündliche Erkrankungen des Mund- und Rachenraums

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
None *

Also Published As

Publication number Publication date
EP1977757A2 (de) 2008-10-08
EP1829548A1 (de) 2007-09-05
EP1977757A3 (de) 2009-04-22
ATE422161T1 (de) 2009-02-15
DK1829548T3 (da) 2009-05-11
SI1829548T1 (sl) 2009-06-30
EP1829548B1 (de) 2009-02-04
PT1829548E (pt) 2009-04-14
DE502006002773D1 (de) 2009-03-19
PL1829548T3 (pl) 2009-07-31
PL1977757T3 (pl) 2018-06-29
ES2662889T3 (es) 2018-04-10
ES2321432T3 (es) 2009-06-05

Similar Documents

Publication Publication Date Title
EP1977757B1 (de) Lutschpastille enthaltend Pelargonium in Kombination mit Plantago
EP2293805B1 (de) Lutschzusammensetzung zur behandlung von entzündlichen erkrankungen des mund- und rachenraums
EP2874600B1 (de) Pharmazeutische zusammensetzung zur behandlung von heiserkeit oder halsschmerzen
EP2367557B1 (de) Zusammensetzung zur behandlung von entzündlichen erkrankungen des mund- und rachenraums
EP1871340B1 (de) Reizlinderndes hustenmittel enthaltend extrakte aus isländischem moos und malve sowie zinkverbindungen
DE202006011920U1 (de) Zusammensetzung zur Behandlung von Rhinitis
EP1639998B1 (de) Schleimdrogenbasierte Lutschtablette gegen entzündliche Erkrankungen des Mund- und Rachenraums
EP3285791B1 (de) Zusammensetzung für die behandlung des hals-/rachenraums
DE20109044U1 (de) Pharmazeutische Zubereitung
EP2617412B1 (de) Zusammensetzung für die topische Behandlung
EP3380109A1 (de) Zusammensetzung zur behandlung von erkältungskrankheiten und allergien
WO2017028977A1 (de) Zusammensetzung für die behandlung des hals-/rachenraums
DE102012003286A1 (de) Kombination aus Lipidtransferproteinen und Phenolderivate enthaltenden Pflanzenstoffen mit lokal-mucosaler Effizienz
DE202006008541U1 (de) Reizlinderndes Hustenmittel
DE202015104316U1 (de) Zusammensetzung für die Behandlung des Hals-/Rachenraums
DE202004016078U1 (de) Schleimdrogenbasierte Lutschtablette gegen entzündliche Erkrankungen des Mund- und Rachenraums
DE102020007979A1 (de) Zusammensetzung zur Behandlung von lnfektionen mit Coronaviren
DE10357110B4 (de) Zusammensetzung zur Behandlung von Zahn- und Zahnfleischerkrankungen
DE202009008263U1 (de) Zusammensetzung zur Behandlung entzündlicher Erkrankungen
DE202005009181U1 (de) Reizlinderndes Hustenmittel
EP2138182A2 (de) Verfahren zur Herstellung eines Arzneimittels auf pflanzlicher Basis
DE202005018338U1 (de) Lutschtablette gegen Hustenreiz und Heiserkeit
EP1238672A1 (de) Pharmazeutisches Kombinationspräparat enthaltend einen Extrakt aus Süssholzwurzel und Eichenrinde
DE10250412A1 (de) Pflanzliches Mittel zur Behandlung von Diabetes

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20080703

AC Divisional application: reference to earlier application

Ref document number: 1829548

Country of ref document: EP

Kind code of ref document: P

AK Designated contracting states

Kind code of ref document: A2

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR

AX Request for extension of the european patent

Extension state: AL BA HR MK YU

PUAL Search report despatched

Free format text: ORIGINAL CODE: 0009013

AK Designated contracting states

Kind code of ref document: A3

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR

AX Request for extension of the european patent

Extension state: AL BA HR MK YU

RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 36/18 20060101ALI20090317BHEP

Ipc: A61K 9/20 20060101ALI20090317BHEP

Ipc: A61P 11/04 20060101ALI20090317BHEP

Ipc: A61K 36/68 20060101AFI20080902BHEP

17Q First examination report despatched

Effective date: 20090602

AKX Designation fees paid

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR

AXX Extension fees paid

Extension state: AL

Payment date: 20080703

Extension state: MK

Payment date: 20080703

Extension state: HR

Payment date: 20080703

Extension state: YU

Payment date: 20080703

Extension state: BA

Payment date: 20080703

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 36/185 20060101ALI20170830BHEP

Ipc: A61K 9/24 20060101ALI20170830BHEP

Ipc: A61K 36/68 20060101AFI20170830BHEP

Ipc: A61P 11/04 20060101ALI20170830BHEP

INTG Intention to grant announced

Effective date: 20171005

GRAS Grant fee paid

Free format text: ORIGINAL CODE: EPIDOSNIGR3

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

AC Divisional application: reference to earlier application

Ref document number: 1829548

Country of ref document: EP

Kind code of ref document: P

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR

AX Request for extension of the european patent

Extension state: AL BA HR MK YU

REG Reference to a national code

Ref country code: GB

Ref legal event code: FG4D

Free format text: NOT ENGLISH

REG Reference to a national code

Ref country code: CH

Ref legal event code: EP

REG Reference to a national code

Ref country code: IE

Ref legal event code: FG4D

Free format text: LANGUAGE OF EP DOCUMENT: GERMAN

REG Reference to a national code

Ref country code: AT

Ref legal event code: REF

Ref document number: 955745

Country of ref document: AT

Kind code of ref document: T

Effective date: 20180115

REG Reference to a national code

Ref country code: DE

Ref legal event code: R096

Ref document number: 502006015761

Country of ref document: DE

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 13

REG Reference to a national code

Ref country code: ES

Ref legal event code: FG2A

Ref document number: 2662889

Country of ref document: ES

Kind code of ref document: T3

Effective date: 20180410

REG Reference to a national code

Ref country code: NL

Ref legal event code: MP

Effective date: 20171220

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: SE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: FI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

REG Reference to a national code

Ref country code: LT

Ref legal event code: MG4D

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: GR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20180321

Ref country code: BG

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20180320

Ref country code: LV

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: NL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: CY

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: EE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: CZ

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: SK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: IS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20180420

Ref country code: RO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

REG Reference to a national code

Ref country code: DE

Ref legal event code: R097

Ref document number: 502006015761

Country of ref document: DE

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

GBPC Gb: european patent ceased through non-payment of renewal fee

Effective date: 20180320

26N No opposition filed

Effective date: 20180921

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: DK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: MC

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

REG Reference to a national code

Ref country code: IE

Ref legal event code: MM4A

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LU

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20180301

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: IE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20180301

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: SI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: GB

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20180320

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: GB

Payment date: 20190222

Year of fee payment: 8

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: ES

Payment date: 20190418

Year of fee payment: 14

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: TR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: HU

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT; INVALID AB INITIO

Effective date: 20060301

Ref country code: PT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

REG Reference to a national code

Ref country code: ES

Ref legal event code: FD2A

Effective date: 20210726

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: IT

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20200301

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: ES

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20200302

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: FR

Payment date: 20230327

Year of fee payment: 18

Ref country code: AT

Payment date: 20230322

Year of fee payment: 18

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: PL

Payment date: 20230221

Year of fee payment: 18

Ref country code: BE

Payment date: 20230321

Year of fee payment: 18

P01 Opt-out of the competence of the unified patent court (upc) registered

Effective date: 20230613

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: CH

Payment date: 20230401

Year of fee payment: 18

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: DE

Payment date: 20240325

Year of fee payment: 19